About Amanda Isabel
Spanish
Native or bilingual
English
Fluent
Portuguese
Conversational
Experience
- Tradegate to Europe S.L.Regulatory Affairs Specialist | Cosmetics & K-Beauty ExpertFASHION AND COSMETICSJune 2024 - Today (2 years)Madrid, Spain• • I optimize the review of technical documentation, ensuring 100% regulatory compliance in cosmetic products, by standardizing evaluation processes.• • I notify a variety of cosmetic products on CPNP and SCPN portals, including perfumes, makeup, and facial/hair cosmetics.• • I manage and evaluate technical documentation for the product information file (PIF), including safety assessment.• • I ensure regulatory compliance in labeling and INCI lists, approving final artwork and meeting deadlines.• • I monitor key regulatory changes (Regulation 1223/2009, REACH, CLP, IFRA, Omnibus, etc.), anticipating impacts on formulations and ingredients, and ensuring dossier adaptation without commercial interruptions.• • I ensure regulatory compliance for exports to the USA, Canada, and the United Kingdom, facilitating access to global markets.• • I prepare, review, and manage technical and safety data sheets, as well as analytical reports (Challenge Test, Stability, Efficacy, etc.).• • I contribute to the success of ISO 9001:2015 and AEMPS audits, ensuring compliance and continuous improvement.• • I respond to customs inspection requirements, reducing retention times and avoiding additional logistical costs.• • I manage cosmetic vigilance and customer complaint processes, resolving incidents and strengthening brand trust.
- Laboratorio Dr. Goya AnálisisQUALITY CONTROL TECHNICIAN AND CLINICAL EVALUATIONSDecember 2023 - June 2024 (6 months)Madrid, Spain• • Microbiological analysis of cosmetics, medical devices, food, food supplements, purified waters, air, etc.• • I executed and interpreted Stability/Compatibility Studies and Challenge Tests for cosmetic products.• • I performed Efficacy and Safety Tests in vivo for cosmetics (use of probes), managed volunteers, and interpreted results.
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Education
- Universidad Complutense de MadridCollaboration Scholarship2023BECA DE COLABORACIÓN
- CEUExpert Course in Safety Assessment and Cosmetic Product Information File2025CURSO DE EXPERTO EN EVALUACIÓN DE SEGURIDAD Y PIF DE PRODUCTOS COSMÉTICOS